The programme module deals with pharmaceutical issues concerning
the formulation of drugs based on peptides and proteins. Students
will also gain insight into analytical and production problems as
well as the regulatory aspects of registering biotechnological
drugs.
The following topics will be dealt with:

A general introduction to the production methods used to produce
peptides by synthesis.

Methods for optimizing the chemical and physical stability of
peptides and proteins, including an introduction to the analytical
methods used for chemical and physical-chemical characterization of
these types of drugs.

There will be emphasis on formulation of solutions and
freeze-dried preparations, and the pharmaceutical formulation
aspects of developing vaccines and alternative administration
methods are also included. Unwanted immunogenicity and
pharmacokinetics of protein drugs will be discussed.

The development of peptide and protein analogues will be
covered.

There will be general description of the documentation necessary
for the pharmaceutical-chemical part of a registration application,
with focus on the special conditions relevant to biotechnological
products.

For project work, students in groups of four to five will
draft a development plan for a protein drug from production of the
drug (the protein) to registration, with the main focus on
(pre-)formulation work. Thus, the project work will include
all of the aspects discussed during the course, and must form the
subject of a written report to be presented orally.

Course certificate:
Report and presentation of project work. Students are expected to
actively participate in the learning process, that is, in the
lectures and in group work (literature searches, discussions within
the group, writing, presenting and defending the report). The
students must also participate in a minimum of 28 hrs of lectures
and in all group presentations.

An attendance scheme will log sufficient attendance. Active
participation requires a signed declaration in the report of all
group members that all group members actively participated. The
report must follow the guidelines layed out in the description of
the group work. All group members must act as opponents to one
other group.
Students with insufficient attendance or insufficient contribution
in the group work may be given extra assignments, such as written
evaluation of the report of other groups or short summaries of
lecture notes and/or book chapters on specific topics.

Marking scale

passed/not passed

Censorship form

No external censorship

Criteria for exam assesment

To pass the course the student must be able
to:

Knowledge

explain and discuss the principles of formulation for peptides
and proteins

explain and identify important degradation pathways of peptides
and proteins

explain and identify the most important methods for
characterizing drugs based on peptides and proteins

Skills

outline the options for the formulation of peptides and
proteins

discuss and elaborate on the scientific literature in the field
of peptide/protein formulation